The narcolepsy drug modafinil should not be approved as a treatment for attention deficit hyperactivity disorder in children until more is learned about a possible link to a serious skin disease, federal advisers said Thursday.
A Food and Drug Administration advisory committee voted 12-1 against recommending modafinil as safe for children with ADHD. Earlier Thursday, the psychopharmacologic drugs panel agreed unanimously that the modafinil works in treating ADHD.
The FDA is not required to follow the recommendations of its advisory committees but usually does.
The committee recommended that Cephalon Inc. undertake a 3,000-patient trial to determine what risk modafinil may pose for Stevens-Johnson Syndrome. Drug reactions cause nearly all cases of the sometimes fatal skin disease, which can produce widespread blistering and rashes, according to The Merck Manual.
The FDA’s drug chief, Dr. Robert Temple, said one out of roughly 900 children involved in earlier studies of the drug developed the disease.
Temple and Cephalon spokeswoman Jenifer Antonacci said the agency and company would discuss the committee’s recommendation. The company does not see a “clear link” between its drug and the skin disease, Antonacci said.
In December 1998, the FDA originally approved modafinil, under the brand name Provigil, to treat adults with sleepiness associated with narcolepsy. The company has proposed calling a higher-dose version of the pill Sparlon when used to treat ADHD.
Other drugs already approved by the FDA for ADHD include Ritalin, Strattera and Adderall.
A different advisory committee recommended on Wednesday that the FDA add warnings to the labels of those and other ADHD drugs on the market alerting doctors and parents to the possible risk of hallucinations in the more than 3 million children receiving the popular medications.
Narcolepsy is marked by recurring episodes of daytime sleep, lasting from a few seconds to an hour. The disease can be merely inconvenient to some people, but disabling and dangerous to others who may fall asleep while driving or operating machinery.